Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia

Usefulness of Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia

This research aims to evaluate the usefulness of lung ultrasound (LUS) for detecting and monitoring fluid overload in patients with severe preeclampsia. Severe preeclampsia is a leading cause of maternal death and illness worldwide, often causing fluid buildup that can lead to a serious complication called pulmonary edema, especially after delivery.

The study will be a prospective, longitudinal observational study with a diagnostic validation component. It will involve patients with a diagnosis of severe preeclampsia who meet specific inclusion criteria. Each participant will undergo a clinical exam and a lung ultrasound, which will assess eight zones of the lungs. The total number of B-lines-a sign of interstitial edema-will be documented.

Data will be collected at three key times: upon admission, in the immediate postpartum period (within 24 hours of delivery), and 7-10 days postpartum. The results from the LUS will be compared to clinical signs like shortness of breath, rapid breathing, crackling sounds in the lungs, and oxygen saturation levels.

The expected impact of this research is to provide evidence that LUS is a valuable, non-invasive, and accessible tool for the early detection of pulmonary congestion in patients with severe preeclampsia. This could lead to improved clinical decision-making and a reduction in maternal respiratory complications.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Pulmonary Edema - Acute
• Intervention / Treatment: Diagnostic test: Lung ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana Martinz, MD; Email: amartinzmd@gmail.com
• Study Contact Backup: Name: Anna C Figueroa, MD; Phone Number: +507 69494250; Email: annacfigue@gmail.com

Study Locations

• Panama
  • Provincia de Panamá
    • Panama City, Provincia de Panamá, Panama
      • Recruiting
      • Saint Thomas Hospital
      • Contact: Osvaldo A Reyes, MD; Phone Number: o11(507)65655041; Email: oreyespanama@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preeclampsia with severe features.
• Gestational age 24 weeks - 41 weeks.

Exclusion Criteria:

• Chronic lung disease.
• Known heart disease.
• Diagnosis of lung edema at admission
• Body mass index > 40
• Need for immediate delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe preeclampsia; Pregnant subjects (24 weeks - 41 weeks) with severe preeclampsia	Diagnostic test: Lung ultrasound; Lung ultrasounf at three moments (at admission, before delivery and immediate post partum) to determine B Lines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Ultrasound evaluation	Three or more B Lines in at least two lung zones using lung ultrasound	One evaluation at admission, another one just before delivery and a final one 24 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	Subjective sensation of difficulty breathing	Report of the symptom by the patient from admission for up to three days
Tachypnea	Respiratory rate above 20 breaths/min	Report of the symptom from admission for up to three days.
Oxygen saturation	Oxygen saturation measured by pulse oxymeter	Report of the value measured by a pulse oxymeter from admission for up to three days

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Investigators: Study Director: Osvaldo Reyes, MD, Saint Thomas Hospital, Panama

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: August 24, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Lung ultrasound; Severe preeclampsia; Pulmonary edema; B lines
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Pulmonary Edema
• Other Study ID Numbers: 4377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No